SHANGHAI WUSHAN INDUSTRIAL CO.

, LTD
ADDNO.128-120 FENGXIANG RD. SHANGHAI CHINA TEL: 021-51098176 FAX: 021-51010173

DONASIS Silicone Gel-filled Mammary Implant


SHANGHAI WUSHAN INDUSTRIAL CO., LTD
ADDNO.128-120 FENGXIANG RD. SHANGHAI CHINA TEL: 021-51098176 FAX: 021-51010173

Rigorous quality control process

DONASIS brand breast implants are permanent silicone gel filled implants designed for mammary augmentation and reconstruction surgery. All implantable grade raw silicone materials used in the manufacture of DONASIS products are made from nusil technology in USA and are designed and tested to meet ISO 13485 biocompatibility requirements. The implants shells are made with silicone elastomer layers showing mechanical characteristics and the silicone gel used for filling is cohesive, safe and aesthetically pleasing. DONASIS brand breast implants offers a large range of sizes from 120cc to 460cc in low or high profile, with smooth or textured surface. IMPLANT SHELL The flexible silicone envelope gives its shape to the implant. It has a trilaminar structure made with several layers of implant grade silicone elastomer including a barrier-coat which prevent silicone from bleeding. The shell has been subjected to extensive integrity testing including elongation, tensile set and tear resistance. It complies with the physical and mechanical testing requirements of the implant standards EN 12180 and EN ISO 14630. Thickness of the shell is rigorously controlled. The surface of the shell can be smooth or textured. The textured surface may reduce capsular contracture. SILICONE GEL The silicone gel used is cohesive enough to reduce its migration in the case of an implant rupture. It complies with implant standard EN 12180, meets ISO 10993 biocompatibility requirements and was designed to pass USP Class VI. Breast implant sealing up DONASIS brand breast implants are sealed up by vulcanisation of a patch on the shell. It maintains optimum mechanical characteristics and very good strength to the area of the shell adjacent to the bonded area. Breast implant traceability Each implant is marked with Company name, batch number and nominal volume in order to allow identification.


SHANGHAI WUSHAN INDUSTRIAL CO., LTD
ADDNO.128-120 FENGXIANG RD. SHANGHAI CHINA TEL: 021-51098176 FAX: 021-51010173

Specification
Round cohesive gel High Profile (99% filled) 3099
Catalogue Number

Size (g)
140 160 180 200 220 240 260 280 300 325 350 375 400 430 460 500 520 560 620

Smooth Surface SC3099140 SC3099160 SC3099180 SC3099200 SC3099220 SC3099240 SC3099260 SC3099280 SC3099300 SC3099325 SC3099350 SC3099375 SC3099400 SC3099430 SC3099460 SC3099500 SC3099520 SC3099560 SC3099620

Textured Surface TC3099140 TC3099160 TC3099180 TC3099200 TC3099220 TC3099240 TC3099260 TC3099280 TC3099300 TC3099325 TC3099350 TC3099375 TC3099400 TC3099430 TC3099460 TC3099500 TC3099520 TC3099560 TC3099620

Micro-Textured Surface MC3099140 MC3099160 MC3099180 MC3099200 MC3099220 MC3099240 MC3099260 MC3099280 MC3099300 MC3099325 MC3099350 MC3099375 MC3099400 MC3099430 MC3099460 MC3099500 MC3099520 MC3099560 MC3099620

Diameter (mm)
77 80 83 87 91 94 97 100 102 105 108 110 112 114 116 118 119 120 122

Height (mm)
42 44 46 48 50 52 54 56 58 59 60 61 62 63 64 65 66 67 69

Round cohesive gel Middle Profile (99% filled) 2099

Catalogue Number

Size (g)
175 195 205 230 250 270 295 325 365 390 425 480 520 560 620

Smooth Surface SC2099175 SC2099195 SC2099205 SC2099230 SC2099250 SC2099270 SC2099295 SC2099325 SC2099365 SC2099390 SC2099425 SC2099480 SC2099520 SC2099560 SC2099620

Textured Surface TC2099175 TC2099195 TC2099205 TC2099230 TC2099250 TC2099270 TC2099295 TC2099325 TC2099365 TC2099390 TC2099425 TC2099480 TC2099520 TC2099560 TC2099620

Micro-Textured Surface MC2099175 MC2099195 MC2099205 MC2099230 MC2099250 MC2099270 MC2099295 MC2099325 MC2099365 MC2099390 MC2099425 MC1099480 MC1099520 MC1099560 MC1099620

Diameter (mm)
95 96 97 101 104 106 107 114 117 121 125 127 130 135 139

Height (mm)
38 40 42 42 43 43 45 46 47 50 51 52 53 54 56

Round cohesive gel Low Profile (99% filled) 1099

Catalogue Number

Size (g)
160 180 200 220 240 260 280 300

Smooth Surface SC1099160 SC1099180 SC1099200 SC1099220 SC1099240 SC1099260 SC1099280 SC1099300

Textured Surface TC1099160 TC1099180 TC1099200 TC1099220 TC1099240 TC1099260 TC1099280 TC1099300

Micro-Textured Surface MC1099160 MC1099180 MC1099200 MC1099220 MC1099240 MC1099260 MC1099280 MC1099300

Diameter (mm)
95 99 100 104 107 108 109 118

Height (mm)
30 31 37 40 40 41 41 42


SHANGHAI WUSHAN INDUSTRIAL CO., LTD
ADDNO.128-120 FENGXIANG RD. SHANGHAI CHINA TEL: 021-51098176 FAX: 021-51010173
320 340 360 380 SC1099320 SC1099340 SC1099360 SC1099380 TC1099320 TC1099340 TC1099360 TC1099380 MC1099320 MC1099340 MC1099360 MC1099380 119 121 124 127 44 44 45 46

Approximate Dimensions: All dimensions detailed in specification charts are approximate and slight variations may occur. Dimensions are measured with the implant placed on a flat surface. DONASIS brand breast implants are supplied sterile in a single packaged unit. GENERAL TECHNICAL INFORMATION 1 The products quality is guaranteed by inspections at all levels of manufacture. All our products are manufactured in a clean room quoted class 100000. The final control is made at the level of packaging. 2 The packaged breast implant sterilisation is made by ethylene oxide according to a validated method in the physical and microbiological field. The shelf life is 3 years from the sterilisation date.

DONASIS brand breast implants conforms to 93/42/CEE European Directive requirements and maintains a quality insurance system according to ISO 13485 NF EN ISO 9001